MAUDE Adverse Event Report: C. R. BARD, INC. PUREWICK FEMALE EXTERNAL CATHETER, NOT MADE NATURAL RUBBER LATEX; COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER

Model Number	PWF030K
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Skin Maceration (4841)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Purewick was placed while the incontinent patient was in the emergency department on [date redacted].On [date redacted], the nurse completed the morning skin check and noticed macerated redness to groin.The purewick was in place.At shift change, nurse noticed reddened area around device.It was unclear if it the area is open.It was difficult to assess due to incontinent urine.Urine vs wound drainage.Suction set up for one canister in room.Paracentesis set up to suction.Unable to connect purewick to suction.Purewick repositioned frequently throughout shift due to patient going to ultrasound for paracentesis and returning.Wound and ostomy care (woc) nurse was consulted.Purewick removed.Patient already on specialty bed.Skin cleansed and barrier cream applied.Woc consult completed [date redacted] with woc nurse's findings as follows: partial thickness tissue loss noted to the labia majora that is linear in presentation consistent with the purewick external catheter.Area measures 3cm x 0.2cm x 0.1cm and 2.6cm x 0.2cm x 0.1cm to the left and right of the labia majora.Red wound base.No drainage noted.Purewick has been removed at this time.Incontinence brief in place at time of assessment.Nursing has specialty bed in place as well as taps and heel boots.Wound classified as a stage 2 pressure injury by woc.The pressure injury had improved during hospitalization.

• Brand Name: PUREWICK FEMALE EXTERNAL CATHETER, NOT MADE NATURAL RUBBER LATEX
• Common Device Name: COLLECTOR, URINE, POWERED, NON INDWELLING CATHETER
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 16706752
• Report Number: 16706752
• Device Sequence Number: 5670640
• Product Code: NZU
• UDI-Device Identifier: 00801741183614
• UDI-Public: 00801741183614
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2023
• Report Date (Section F): 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PWF030K
• Device Catalogue Number: PWF030K
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Race: White
• Date Report Sent to FDA: 03/30/2023